drugset / Trial / NCT00640497

Anti-CD3 & Anti-CD7 Ricin A Immunotoxin-Combination for Acute Graft Versus Host Disease

NCT00640497 ↗

Phase 1/2 Withdrawn 12 enrolled Henogen
NaSingle-groupOpen-labelTreatment

Summary

In this study, a combination of two T-cell directed antibodies both conjugated to a cell-killing toxin will be evaluated. Previous in vitro studies have demonstrated that this so-called immunotoxin-combination (IT-combination) acts synergistically in eliminating T cells. In a subsequent clinical pilot-study, the IT-combination has generated encouraging results when applied as third line therapy. Extensive biological and clinical responses could be noted in the absence of severe acute toxicities. Building on this experience, the current study aims at evaluating the characteristics of the IT-combination when administered in an earlier phase of the disease, i.e. as second line instead of as third line therapy.

Timeline

Start
2010-01
Primary completion
2012-01
Completion
2012-01

Outcome

Outcome not reported

Stopped: “Unavailability of investigational product”

Drugs

EvaluationDrugModalityDoseRoute
Subject anti-CD3 Monoclonal antibody — —
Subject anti-CD7 Monoclonal antibody — —